Status:
RECRUITING
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
1-45 years
Brief Summary
Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection a...
Detailed Description
Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A study participant must satisfy the following criteria to be enrolled in this study:
- Pregnant women aged 15-45 years and their newborn infants who are residents of the district of Ouelessebougou for at least one year at the time of enrollment; OR
- Children who previously participated in the 1st cohort of "pregnant women and their newborn infants", OR
- Children aged 3 years or less, who are residents of the district of Ouelessebougou for at least one year at the time of enrollment, OR
- Febrile hospitalized children (aged 0-10 years), including those with positive and negative blood smears for P. falciparum in Ouelessebougou or the pediatric service of Gabriel Toure Hospital in Bamako. Febrile non-hospitalized children (aged 0-10 years) with non-severe malaria will be recruited at outpatient clinics in Ouelessebougou district health hospital and nearby facilities, with no chronic or serious illness.
- Pregnant women aged 15-25 in Ouelessebougou district health centers or maternity unit of Gabriel Toure Hospital in Bamako and for a case-control study of pregnancy malaria and preeclampsia. Cases include women with signs/symptoms of preeclampsia. Control pregnant women without signs/symptoms of preeclampsia will be recruited sequentially after identification of individual cases, matched for parity, age (+/-2 years) and pregnancy trimester.
- The study participant or parent/guardian understands the study and gives informed consent for participation of themselves and/or their child, and agrees to have samples stored.
- EXCLUSION CRITERIA:
- A participant will be excluded from the study if any one or more of the following criteria are met:
- Chronic, debilitating illness, other than malaria, determined by history and physical examination of mother or study participant.
- Conditions that in the judgment of the investigator could increase the risk to the volunteer.
- History of previous participation in a malaria vaccine trial.
Exclusion
Key Trial Info
Start Date :
August 30 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT01168271
Start Date
August 30 2010
Last Update
January 8 2026
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Gabriel Toure Hospital
Bamako, Mali
2
Ouelessebougou Clinical Research Center
Wolossébougou, Mali